Monday, December 09, 2013

Learned intermediary doctrine doesn't bar claim at pleading stage

Plaintiffs brought a putative class action under the
consumer protection laws of California, Massachusetts, Missouri, and New York,
and Saavedra also brought individual causes of action for breach of warranty,
strict product liability, etc. under California law.The claims were based on Eli Lilly’s
marketing of Cymbalta, an antidepressant.

Cymbalta users risk significant withdrawal symptoms when
they stop taking it, including dizziness, nausea, headache, fatigue,
paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety,
hyperhidrosis, and vertigo.The label
warns that these (except for nightmares) occurred in 1% or more of patients who
tapered or stopped Cymbalta. Plaintiffs alleged that this label didn’t
accurately inform consumers or healthcare professionals of the frequency,
severity, and duration of withdrawal.They alleged that studies from at least 2005 have found that 44-50% of
users experience withdrawal, and about half of those are moderate or persistent
while 10% experience severe symptoms. The plaintiffs alleged that they wouldn’t
have begun taking Cymbalta had they known the truth.

Eli Lilly tried to get rid of the class claims using the
learned intermediary doctrine, which provides that “a drug manufacturer has no
duty to warn the ultimate consumer of potential side-effects of prescription
medication, so long as adequate warnings are given to the prescribing
physician.”(Why this should be so in an
age of DTC drug marketing is left for the reader.)This precludes recovery for strict liability
and negligence when manufacturers fail to warn consumers about side effects if
the warning given to doctors is adequate.Traditionally, the doctrine is applied either at summary judgment or at
trial, not at the motion to dismiss stage.One Pennsylvania case found that consumers couldn’t state a claim under
Pennsylvania’s consumer protection law for failing to disclose known side
effects.But “this holding is grounded
in a significant extension of the learned intermediary doctrine, one that has
not been applied to any of the consumer protection claims at issue in this
case.”The Pennsylvania court ruled that
defendants had no duty to disclose any prescription drug information directly
to the consumer plaintiff.

The court here declined to follow this ruling.“Every claim susceptible to the learned
intermediary doctrine has the chain of relationships described by the court:
the duty owed by the manufacturers is to adequately warn physicians, who in
turn must warn their patients.” But most of the case law doesn’t go that far;
instead, the cases hold that proof that a manufacturer adequately warned a
doctor provides immunity from liability.The court was unwilling to “bar every cause of action by a consumer
against a drug manufacturer, even if the manufacturer had inadequately warned
physicians.”

It is true that all the consumer protection laws at issue,
like Pennsylvania’s, have a causation element, or, in some jurisdictions,
“justified reliance.”But, though some
federal courts interpreting Pennsylvania law have reasoned that justifiable
reliance/causation can’t be present when the pharmaceutical company didn’t sell
directly to the patient, this “threatens to swallow up any cause of action
brought against a drug manufacturer for failure to warn, as every claim—whether
derived from statute or common-law tort—includes an element of causation or
justified reliance.”Instead, the court
predicted that the various jurisdictions would not bar plaintiffs’ consumer
protection claims.California law by its
terms is to be “liberally construed” to protect consumers beyond traditional
torts (and so are the other relevant laws).The court emphasized that this was not a ruling that the learned
intermediary doctrine didn’t apply; there was a good argument that it did, so
plaintiffs would lose if Eli Lilly adequately warned the prescribing
physicians.

The court also rejected Eli Lilly’s preemption and primary
jurisdiction arguments.Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), which found preemption of certain
claims related to medical devices, wasn’t directly on point, and there’s a
presumption against preemption of state laws operating in traditional state
domains.Eli Lilly tried to characterize
plaintiffs’ claims as “fraud on the FDA” claims. “Yet Defendant inexplicably
ignores the Supreme Court’s subsequent, and more relevant decision in Wyeth v.
Levine, 555 U .S. 555 (2007).”Wyeth allowed a state failure-to-warn
claim based on an allegedly inadequate label; the manufacturer could be liable
for failing to update the label based on newly acquired information.

Likewise, the primary jurisdiction doctrine would only apply
if a claim required resolution of an issue of first impression, or of a
particularly complicated issue that Congress committed to the FDA, and if protection
of the integrity of the regulatory scheme dictated preliminary resort to the FDA.
The claims at issue here presented neither “an issue of first impression” nor a
“particularly complicated issue,” but rather a straightforward
failure-to-warn/misleadingness claim.

Eli Lilly then argued that a reasonable consumer wouldn’t be
misled because the warning complied with FDA regulations—but Wyeth is clearly to the contrary.And Lilly’s argument that the “reasonable
consumer” here is the prescribing doctors was just a restatement of the
already-rejected learned intermediary argument.

However, the court did hold that plaintiffs lacked standing
to seek injunctive and declaratory relief, because they knew the truth
now.(I continue to think this is wacky
in a class action.Something very
strange has happened to standing in general in the past decade, and it invites
a comprehensive examination, which perhaps some scholar is carrying on now.)

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